The Recall Desk

FDA (Devices) recall action 83909

Applied Medical Resources Corp recalled 2 products on 2019-11-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-11-27
Critical
0
Units
—

Why these products were recalled

Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Devices)··2019-11-27

    Applied Medical Recalls Epix Electrosurgical Probes Due to Tip Insulation Shifting

    Applied Medical Resources Corp is recalling Epix Electrosurgical Probes because the tip insulation may shift unintentionally. The recall affects 28 units in the US and 112 units internationally.

    Product
    Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-11-27

    Applied Medical Recalls GelPOINT Path Transanal Procedural Packs Due to Insulation Shift

    Applied Medical Resources Corp is recalling GelPOINT Path Transanal Procedural Packs because the tip insulation on the electrosurgical probes may shift unintentionally.

    Product
    GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform variou
    Category
    Distribution
    0 states